Newsletter | October 1, 2023

Best of September: Top 5 Insights in Clinical Research

Top 5 Insights In Clinical Research

Clinical Leader
The Best Of September

TOP 5 INSIGHTS IN CLINICAL RESEARCH
SEPTEMBER EDITION

#1 Navigating The Hype Of AI In Clinical Research

When you consider the rising cost of healthcare in America, a major physician shortage, and economic headwinds stirring fear across the field, we can’t afford to not use AI. We shouldn’t be asking ourselves questions of why, but rather, why not. But that begs a new question: Why haven’t we seen the impact, adoption, and value of AI more broadly across clinical research?

#2 What You Need To Know About The New ICH GCP E6(R3) Draft Guidelines

The ICH’s updated draft guidelines for planning, designing, conducting, recording, and reporting clinical trials introduce a dynamic, risk-based approach to trial design and create universal standards for data. Understanding these guidelines is critical to designing and executing successful clinical trials.

#3 Why Do So Many Alzheimer’s Clinical Trials Fail?

Over the past 20 years, 98% of Alzheimer’s disease treatment clinical trials have failed. But why? INmune Bio CEO and Chief Medical Officer RJ Tesi, MD explores what he says are the three main reasons why so few AD clinical trials succeed and offers guidance on how to improve the chance of success.

#4 What Do The New FDA Postmarketing Data On Underrepresented Populations Draft Guidelines Mean For Pharmaceutical Companies?

New FDA draft guidelines create a path forward for companies that need time after approval to thoroughly examine a drug’s efficacy and safety for diverse, underrepresented patient populations. Explore why these guidelines are necessary, what they mean for sponsors, and when they will be required. 

#5 AI's Potential To Improve Clinical Operations, Trial Matching

With the rise of generative AI models like ChatGPT, there come questions of how this technology can be used in industry, especially in healthcare. Microsoft's Dr. Hoifung Poon explains how AI (specifically, large language models) can be used to improve patient care and clinical workflows by making it easier to match patients to trials.